The purpose of this study is to conduct a preliminary evaluation of the efficacy of combined medication and psychotherapy for generalized anxiety disorder (GAD). The general goals of the current study are to conduct a late stage treatment development study. The goal of this stage of research is to provide a preliminary answer to the question and to gather data to estimate intervention parameters (e.g., effect size, attrition rates, response rates) that would assist in planning further research.

This cognitive behavioral therapy for GAD has a cognitive restructuring component and an applied relaxation component. Patients will be educated about the nature of anxiety and be trained in the recognition and monitoring of situational, physiological, cognitive, and behavioral cues associated with anxious responding. They will be guided through copings skill rehearsals in addition to imaginal and in vivo exposure to anxiety cues. This cognitive behavioral treatment will consist of 1 to 1.5 hour sessions of psychotherapy, which will be held once weekly over a period of 12 weeks.

Secondary Hypotheses: Combined CBT plus medication will be superior to medication alone on a number of secondary outcome measures, including the core feature of GAD (worry), depressive symptoms, functional impairment, and quality of life.

Additional Exploratory Aim: We will explore the comparative relapse rates for the combined CBT plus medication treatment and the medication alone treatment condition at 6-month follow-up.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

GAD diagnosis by structured interview

Hamilton Anxiety Scale score of 18 or less

Clinical Global Impressions Scale score of at least 4

Hamilton Depression Scale score of 18 or less

Hamilton Depression Scale suicide item score less than 2

Use of an effective form of contraception throughout the s

Exclusion Criteria:

Hypersensitivity to venlafaxine XR

History of seizures

Episode of major depressive disorder in the previous 6 months

History of any psychotic illness, bipolar disorder, or dementia

Substance abuse and dependence during the past 6 months

Other anxiety disorders with the exception of social phobia as long as GAD is primary

Regular use of anxiolytics or antidepressants within 7 days of study onset

Use of fluoxetine or monoamine oxidase inhibitors within 28 days of study onset (low dose usage of benzodiazepines will not prevent participation)

Use of other psychotic medication besides benzodiazepines

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00620776